Prescription drug · ANDA
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide NDC 63629-8615
Brompheniramine maleate 2 mg/5mL + 2 more ingredients · Syrup · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8615-1 | 63629861501 | 118 mL in 1 BOTTLE, PLASTIC (63629-8615-1)Marketed from Feb 6, 2015 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
- Generic name (nonproprietary)
- brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
- Active ingredients
- Brompheniramine maleate — 2 mg/5mLPseudoephedrine hydrochloride — 30 mg/5mLDextromethorphan hydrobromide — 10 mg/5mL
- Dosage form
- Syrup
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205292
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 63629-8615_9c7a1cff-ccac-4cdd-9afe-79dadf312617SPL ID 9c7a1cff-ccac-4cdd-9afe-79dadf312617SPL set ID 85b98fa3-376c-41a3-b3c1-0c739d903a22RxCUI 1357010UNII IXA7C9ZN03, 6V9V2RYJ8N, 9D2RTI9KYH
- Pharmacologic class
- Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-Adrenergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N463629861501followed by a unit qualifier and the quantityPackage 63629-8615-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205292
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | Brompheniramine maleate 2 mg/5mL + 2 more ingredients | SyrupOral | Proficient Rx LP | 63187-664 |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | Brompheniramine maleate 2 mg/5mL + 2 more ingredients | SyrupOral | Padagis US LLC | 0574-1104 |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | Brompheniramine maleate 2 mg/5mL + 2 more ingredients | SyrupOral | REMEDYREPACK INC. | 70518-4526 |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | Brompheniramine maleate 2 mg/5mL + 2 more ingredients | SyrupOral | Bryant Ranch Prepack | 63629-8616 |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | Brompheniramine maleate 2 mg/5mL + 2 more ingredients | SyrupOral | A-S Medication Solutions | 50090-5625 |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | Brompheniramine maleate 2 mg/5mL + 2 more ingredients | SyrupOral | Bryant Ranch Prepack | 72162-1123 |